Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003742580

FEI Number

3003742580

Entity Name

DNA GENOTEK, INC.

City/State/Country

Ottawa Ontario, CA

Establishment Address

3000 - 500 Palladium Drive, Ottawa Ontario K2V 1C2, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DNA GENOTEK, INC. (Owner Number: 9054962)

Owner / Operator Contact Address

3000 - 500 Palladium Drive, Ottawa, CA-ON K2V 1C2, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K110701

PMA Number

N/A

All Registered Proprietary Names

Oragene Dx (OGD-510, OGD-600, OGD-610, OGD-675) OMNIgene ORAL (OM-501, OMR-110, OMR-120) OMNIgene GUT (OMR-200) OMNIgene VAGINAL (OMR-130) OMNIgene SKIN (OMR-140) OMNImet GUT (OME-200) OMNIgene GUT DNA & RNA (OMR-205) N00345_RUO Colli-Pee UAS FV-5010-RUO N00260_RUO Colli-Pee UCM FV-5004-RUO N00342_RUO Colli-Pee UAS FV-5040-RUO N00339_PROTO Colli-Pee UAS FV-5020-PROTO N00327_RUO Colli-Pee UCM FV-5010-RUO N00269_RUO Colli-Pee Large Volumes RUO N00290_RUO Colli-Pee 4 mL RUO N00176_RUO Colli-Pee UCM FV-5020-RUO ORAcollect Dx (OCD-100, OCD-100A) Oragene RNA (RE-100) ORAcollect for Pediatrics (OC-175) HEMAgene BUFFY COAT (HG-BCD-50, HG-BCD-250) Colli-Pee FV-5040 Urine Collection Container Colli-Pee UCM FV-5003b Urine Collection Container Colli-Pee UCM FV-5004 Urine Collection Container Colli-Pee UCM FV-5010 Urine Collection Container Colli-Pee FV-5010 Urine Collection Container Colli-Pee FV-5004 Urine Collection Container Colli-Pee FV-5020c Urine Collection Container Colli-Pee UCM FV-5020 Urine Collection Container Colli-Pee FV-5020 Urine Collection Container Colli-Pee UAS FV-5040 Urine Collection Container OMNIgene GUT Dx OMD 200 Colli-PeeDx Urine Collection Kit ORAcollect Dx (OCD-100, OCD-100A) OMNIgene ORAL (OM-505; OME-505) ORAcollect RNA (ORE-100) Oragene Dx (OGD-500, OGD-575)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	Class 2	862.1675	2016-06-20
OTT	Research Use Only/Microbiology	Unknown	Class N	N/A	2012-01-27
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	Class 2	862.1675	2016-06-03
OTV	Research Use Only/Clinical Chemistry Devices	Unknown	Class N	N/A	2012-01-27
OTQ	Research Use Only/Hematology Devices	Unknown	Class N	N/A	2015-01-23
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2007-11-12
QPO	Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples	Microbiology	Class 2	866.2952	2021-11-18
SIH	N/A	N/A	Class N/A	N/A	2026-06-11
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	Class 2	862.1675	2022-11-04
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2020-10-26
QPO	Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples	Microbiology	Class 2	866.2952	2023-10-18
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	Class 2	862.1675	2012-01-16

Official Correspondent

No official correspondent registered.

US Agent Details

Tiffany Miller Business: ORASURE TECHNOLOGIES INC. Email: tmiller@orasure.com Phone: (610) 8821820

Related Public Records

Same Entity

DNA GENOTEK, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K003761	Medical Packaging Corp.	NAT - NUCLEIC ACID TRANSPORT	2001-05-31

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003742580. Last updated year: 2026. Please use registration number 3003742580 when referencing this establishment in official correspondence.